Egyptian Drug Authority Authorizes Biomerica’s Complete Screening Test Portfolio




Egyptian Drug Authority Authorizes Biomerica’s Complete Screening Test Portfolio

Authorization Covers Multiple Screening Tests for Cancer and Chronic Disease Risk Detection

• Portfolio includes tests for colorectal disease, breast self exam, prostate disease, kidney disease, and H. pylori infection

• Designed for early detection of conditions that are related to the most common cancers and chronic diseases

• Rapid, easy-to-use, and cost-effective screening for mass and individual use

IRVINE, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) — Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced diagnostic solutions, announced today that the Egyptian Drug Authority (EDA) has granted authorization for Biomerica’s complete portfolio of rapid tests, enabling broad access to simple, rapid, and affordable early detection tools for conditions associated with cancers and chronic diseases across Egypt.

This authorization allows Biomerica’s screening products to be marketed and distributed throughout Egypt, supporting early identification of conditions associated with colorectal, breast, and prostate cancers, as well as chronic diseases including kidney disease and Helicobacter pylori infection.

Comprehensive Screening Portfolio Now Authorized in Egypt

The EDA authorization covers the following Biomerica at-home tests:

• EZ Detect™ Colon Disease Test – The most convenient fecal occult blood test (FOBT) that detects hidden blood in stool, an early warning sign of colorectal diseases such as polyps and colorectal cancer. Results are available within two minutes, with no stool handling required.
• Aware^® Breast Self Exam – An aid designed to enhance breast self examination by improving tactile sensitivity and allowing users to detect changes in breast tissue more effectively, supporting early detection of breast abnormalities, including potential indicators of cancer.
• Fortel Prostate (PSA) Screening Test – A rapid lateral flow test using a finger-prick whole blood sample to detect elevated Prostate Specific Antigen (PSA) levels, which may indicate prostate disease including prostate cancer.
• Fortel Kidney Disease (Microalbumin) Screening Test – Detects elevated levels of human albumin in urine, an early marker of possible kidney damage, supporting early identification of chronic kidney disease risk.
• Fortel Ulcer (H. pylori) Screening Test – A rapid whole blood test detecting antibodies to Helicobacter pylori infection, which is associated with gastritis, ulcers, and in some cases stomach cancer.

All tests are designed for point-of-care use enabling deployment across diverse clinical and community settings, including regions with limited infrastructure. They provide quick results within minutes, and eliminate the need for laboratory sample processing, reinforcing Biomerica’s commitment to accessible preventive healthcare.

A Significant Unmet Need in Egypt for Screening

Colorectal Cancer (CRC) is a moderately common cancer in Egypt (7th most common) with roughly 5 – 10 cases per 100,000 persons per year, with rising diagnoses at younger ages and a high proportion of cases detected at late stages.

According to the International Agency for Research on Cancer (IARC)/Global Cancer Observatory (GLOBOCAN) the age-standardized incidence rate (ASR, world standard) for breast cancer in females is about 55.4 per 100,000 persons per year. Breast cancer is the most common cancer among women in Egypt by incidence. The mortality outcomes are comparatively worse, which are influenced by later stage at diagnosis as screening and early detection are less prevalent than in high-income countries.

Prostate Cancer is the fourth most common cancer in Egypt with increasing incidence.

Research shows that approximately 13% of adults in Egypt are living with chronic kidney disease according to a population analysis published in the Journal of Public Health in Africa. Additionally, CKD ranked among the top five causes of death in Egypt from 2009 to 2019, highlighting the severity and increasing burden of the disease.

H. pylori infection in Egypt is highly prevalent; studies report varying prevalences between 50 to 70%, likely affecting a majority of children and many adults.

Strengthening Egypt’s Preventive Healthcare Infrastructure

These screening tools target populations most at risk, including individuals with diabetes, hypertension, family histories of cancer, and other chronic health conditions. By empowering individuals with private, reliable, and rapid home testing, these products support national public health efforts to shift disease detection earlier, improve outcomes, and reduce long-term healthcare costs.

“Authorization of our full screening portfolio by the Egyptian Drug Authority represents a milestone in expanding access to early detection in a region with growing chronic disease and cancer burdens,” said Zack Irani, CEO of Biomerica. “This authorization provides scalable tools for both individual testing and screening initiatives.”

Designed for Population-Level Screening

Biomerica’s screening tests are positioned not only for consumer use but also for public health campaigns, clinics, pharmacies, and hospital-based screening programs, offering:

• No lab processing or mailing requirements
• Low-cost, scalable solutions for mass screening
• Quick turnaround for immediate decision-making
• Privacy and convenience for patients

These features allow healthcare providers and government agencies to deploy large-scale screening programs efficiently, particularly in underserved and rural areas.

Expanding Biomerica’s Presence in the Middle East & North Africa

This authorization strengthens Biomerica’s strategic expansion across the Middle East and North Africa (MENA) region and reinforces its role as a provider of affordable, patient-centered diagnostic solutions aligned with global preventive care trends.

About Biomerica (NASDAQ: BMRA)

Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and in physicians’ offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company’s products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica primarily focuses on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development.

The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the Company’s current and future sales, revenues, overhead, expenses, operations, margins, cost of goods, and earnings; the efficacy, performance, and potential market adoption of the Company’s products and tests, including but not limited to the EZ Detect™ Colon Disease Test, Aware^® Breast Self Exam, Prostate (PSA) screening Test, Fortel^® Kidney Disease (Microalbumin) Test, H. pylori screening Test, and the Company’s broader screening test portfolio; the Company’s ability to obtain and maintain regulatory authorizations, clearances, or approvals necessary to market or sell any of its current or future products; the Company’s ability to expand into additional domestic or international markets; the uniqueness, clinical utility, accuracy, potential benefits, and commercial acceptance of the Company’s products; pricing of the Company’s test kits; domestic and/or international demand for the Company’s products; future availability of the Company’s products in pharmacies, clinics, hospitals, or through public health programs; and the potential use of the Company’s products by physicians and healthcare organizations. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, including, without limitation: results of studies testing the efficacy or performance of the Company’s products; regulatory requirements and the ability to obtain or maintain necessary approvals; supply-chain challenges and dependence on third-party manufacturers and shipping carriers; governmental import/export regulations; competitive products and companies with significantly greater financial and operational resources; governmental healthcare policies; demand for the Company’s various tests; pricing pressures; reimbursement challenges; the Company’s ability to raise additional capital; general economic conditions; and the Company’s ability to protect its intellectual property. Accordingly, actual results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. The Company is under no obligation to update any forward-looking statements after the date of this release.

Corporate Contact:
Zack Irani | CEO
p. 949.645.2111
www.biomerica.com

Source: Biomerica

Cadrenal Therapeutics Acquires VLX-1005, a First-in-Class Phase 2 12-LOX Inhibitor for Patients with Heparin-Induced Thrombocytopenia (HIT)




Cadrenal Therapeutics Acquires VLX-1005, a First-in-Class Phase 2 12-LOX Inhibitor for Patients with Heparin-Induced Thrombocytopenia (HIT)

• Novel first-in-class therapeutic targeting a key immune signaling pathway and the underlying cause of HIT
• It is the first and only potent, highly selective inhibitor of human 12-LOX in clinical testing, distinguishing it from related compounds.
• Orphan Drug and Fast Track designations from the FDA

PONTE VEDRA, Fla., Dec. 11, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today announced the acquisition of VLX-1005 and related 12-lipoxygenase (12-LOX) assets from Veralox Therapeutics (“Veralox”). The acquisition immediately strengthens Cadrenal’s pipeline with a late-stage, first-in-class drug candidate targeting a critical immune signaling pathway. This acquisition addresses yet another underserved therapeutic opportunity in the $40 billion global anticoagulation market.

VLX-1005 is a novel, potent, selective small-molecule inhibitor of 12-LOX, a key pathway driving immune platelet-mediated inflammation and a contributor to the pathogenesis of HIT. This potentially life-threatening complication can occur in up to 5% of patients exposed to heparin – the most commonly used parenteral anticoagulant – regardless of dose, schedule, or route of administration. HIT antibodies can cause catastrophic and life-threatening arterial and venous thrombosis. Approximately 300,000 patients in the United States are evaluated each year for suspected HIT, and an estimated 56,000 confirmed diagnoses occur each year. Mortality and thromboembolic event (TE) rates remain high despite currently available therapies.

Two Phase 1 studies of VLX-1005 in healthy participants have demonstrated that VLX-1005 was well tolerated, with no deaths, no serious adverse events, and no trend in adverse event reporting with increasing doses. A recent Phase 2 study (VLX-1005-003) evaluated VLX-1005 in individuals with suspected HIT, and interim results demonstrated encouraging reductions in thromboembolic events. These events have become a preferred, clinically meaningful endpoint for regulators, clinicians, and payers, given the rising rates observed in current HIT populations.

VLX-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation therapeutics targeting 12-LOX are also under development for type 1 diabetes and other immune-mediated and inflammatory diseases.

“We are pleased the advancement of VLX-1005 for the treatment of HIT will continue under the leadership of Cadrenal,” said Matthew Boxer, Co-Founder of Veralox Therapeutics. “The program has found a home in Cadrenal, where it aligns with a shared vision and excitement regarding the promise 12-LOX technology may offer patients.”

“With the acquisition of VLX-1005, Cadrenal continues to advance novel therapeutics to treat or prevent thrombosis in high-risk patients,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “HIT remains a dangerous condition without a therapy that addresses its immune-driven biology. The emerging data from VLX-1005 suggest meaningful potential to improve patient outcomes while maintaining favorable tolerability. We believe this is a compelling strategic addition to our pipeline, with the market size for HIT reaching $1 billion in the US and EU.”

Under the terms of the acquisition agreement, Veralox is eligible to receive upfront and milestone payments contingent on the achievement of specified future clinical and regulatory milestones. Additionally, Veralox will be entitled to royalties on global sales of the acquired assets upon future commercialization. The structure and terms of the agreement enable Cadrenal to allocate capital to advancing the clinical development of VLX-1005.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding advancing VLX-1005 for the treatment of HIT; continuing to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the emerging data from VLX-1005 suggesting meaningful potential to improve patient outcomes while maintaining a favorable safety profile; VLX-1005 being a compelling strategic addition to Cadrenal’s pipeline; the payment to Veralox of milestone payments contingent upon the achievement of certain future clinical and regulatory milestones as well as royalties on global sales of the acquired assets upon future commercialization; the structure and terms of the agreement enabling Cadrenal to allocate capital to advancing the clinical development of VLX-1005; and developing transformative therapeutics to overcome the limitations of current anticoagulation therapy. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Cadrenal Therapeutics Acquires VLX-1005, a First-in-Class Phase 2 12-LOX Inhibitor for Patients with Heparin-Induced Thrombocytopenia (HIT)




Cadrenal Therapeutics Acquires VLX-1005, a First-in-Class Phase 2 12-LOX Inhibitor for Patients with Heparin-Induced Thrombocytopenia (HIT)

• Novel first-in-class therapeutic targeting a key immune signaling pathway and the underlying cause of HIT
• It is the first and only potent, highly selective inhibitor of human 12-LOX in clinical testing, distinguishing it from related compounds.
• Orphan Drug and Fast Track designations from the FDA

PONTE VEDRA, Fla., Dec. 11, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today announced the acquisition of VLX-1005 and related 12-lipoxygenase (12-LOX) assets from Veralox Therapeutics (“Veralox”). The acquisition immediately strengthens Cadrenal’s pipeline with a late-stage, first-in-class drug candidate targeting a critical immune signaling pathway. This acquisition addresses yet another underserved therapeutic opportunity in the $40 billion global anticoagulation market.

VLX-1005 is a novel, potent, selective small-molecule inhibitor of 12-LOX, a key pathway driving immune platelet-mediated inflammation and a contributor to the pathogenesis of HIT. This potentially life-threatening complication can occur in up to 5% of patients exposed to heparin – the most commonly used parenteral anticoagulant – regardless of dose, schedule, or route of administration. HIT antibodies can cause catastrophic and life-threatening arterial and venous thrombosis. Approximately 300,000 patients in the United States are evaluated each year for suspected HIT, and an estimated 56,000 confirmed diagnoses occur each year. Mortality and thromboembolic event (TE) rates remain high despite currently available therapies.

Two Phase 1 studies of VLX-1005 in healthy participants have demonstrated that VLX-1005 was well tolerated, with no deaths, no serious adverse events, and no trend in adverse event reporting with increasing doses. A recent Phase 2 study (VLX-1005-003) evaluated VLX-1005 in individuals with suspected HIT, and interim results demonstrated encouraging reductions in thromboembolic events. These events have become a preferred, clinically meaningful endpoint for regulators, clinicians, and payers, given the rising rates observed in current HIT populations.

VLX-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation therapeutics targeting 12-LOX are also under development for type 1 diabetes and other immune-mediated and inflammatory diseases.

“We are pleased the advancement of VLX-1005 for the treatment of HIT will continue under the leadership of Cadrenal,” said Matthew Boxer, Co-Founder of Veralox Therapeutics. “The program has found a home in Cadrenal, where it aligns with a shared vision and excitement regarding the promise 12-LOX technology may offer patients.”

“With the acquisition of VLX-1005, Cadrenal continues to advance novel therapeutics to treat or prevent thrombosis in high-risk patients,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “HIT remains a dangerous condition without a therapy that addresses its immune-driven biology. The emerging data from VLX-1005 suggest meaningful potential to improve patient outcomes while maintaining favorable tolerability. We believe this is a compelling strategic addition to our pipeline, with the market size for HIT reaching $1 billion in the US and EU.”

Under the terms of the acquisition agreement, Veralox is eligible to receive upfront and milestone payments contingent on the achievement of specified future clinical and regulatory milestones. Additionally, Veralox will be entitled to royalties on global sales of the acquired assets upon future commercialization. The structure and terms of the agreement enable Cadrenal to allocate capital to advancing the clinical development of VLX-1005.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding advancing VLX-1005 for the treatment of HIT; continuing to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the emerging data from VLX-1005 suggesting meaningful potential to improve patient outcomes while maintaining a favorable safety profile; VLX-1005 being a compelling strategic addition to Cadrenal’s pipeline; the payment to Veralox of milestone payments contingent upon the achievement of certain future clinical and regulatory milestones as well as royalties on global sales of the acquired assets upon future commercialization; the structure and terms of the agreement enabling Cadrenal to allocate capital to advancing the clinical development of VLX-1005; and developing transformative therapeutics to overcome the limitations of current anticoagulation therapy. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

Cadrenal Therapeutics Acquires VLX-1005, a First-in-Class Phase 2 12-LOX Inhibitor for Patients with Heparin-Induced Thrombocytopenia (HIT)




Cadrenal Therapeutics Acquires VLX-1005, a First-in-Class Phase 2 12-LOX Inhibitor for Patients with Heparin-Induced Thrombocytopenia (HIT)

• Novel first-in-class therapeutic targeting a key immune signaling pathway and the underlying cause of HIT
• It is the first and only potent, highly selective inhibitor of human 12-LOX in clinical testing, distinguishing it from related compounds.
• Orphan Drug and Fast Track designations from the FDA

PONTE VEDRA, Fla., Dec. 11, 2025 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today announced the acquisition of VLX-1005 and related 12-lipoxygenase (12-LOX) assets from Veralox Therapeutics (“Veralox”). The acquisition immediately strengthens Cadrenal’s pipeline with a late-stage, first-in-class drug candidate targeting a critical immune signaling pathway. This acquisition addresses yet another underserved therapeutic opportunity in the $40 billion global anticoagulation market.

VLX-1005 is a novel, potent, selective small-molecule inhibitor of 12-LOX, a key pathway driving immune platelet-mediated inflammation and a contributor to the pathogenesis of HIT. This potentially life-threatening complication can occur in up to 5% of patients exposed to heparin – the most commonly used parenteral anticoagulant – regardless of dose, schedule, or route of administration. HIT antibodies can cause catastrophic and life-threatening arterial and venous thrombosis. Approximately 300,000 patients in the United States are evaluated each year for suspected HIT, and an estimated 56,000 confirmed diagnoses occur each year. Mortality and thromboembolic event (TE) rates remain high despite currently available therapies.

Two Phase 1 studies of VLX-1005 in healthy participants have demonstrated that VLX-1005 was well tolerated, with no deaths, no serious adverse events, and no trend in adverse event reporting with increasing doses. A recent Phase 2 study (VLX-1005-003) evaluated VLX-1005 in individuals with suspected HIT, and interim results demonstrated encouraging reductions in thromboembolic events. These events have become a preferred, clinically meaningful endpoint for regulators, clinicians, and payers, given the rising rates observed in current HIT populations.

VLX-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation therapeutics targeting 12-LOX are also under development for type 1 diabetes and other immune-mediated and inflammatory diseases.

“We are pleased the advancement of VLX-1005 for the treatment of HIT will continue under the leadership of Cadrenal,” said Matthew Boxer, Co-Founder of Veralox Therapeutics. “The program has found a home in Cadrenal, where it aligns with a shared vision and excitement regarding the promise 12-LOX technology may offer patients.”

“With the acquisition of VLX-1005, Cadrenal continues to advance novel therapeutics to treat or prevent thrombosis in high-risk patients,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “HIT remains a dangerous condition without a therapy that addresses its immune-driven biology. The emerging data from VLX-1005 suggest meaningful potential to improve patient outcomes while maintaining favorable tolerability. We believe this is a compelling strategic addition to our pipeline, with the market size for HIT reaching $1 billion in the US and EU.”

Under the terms of the acquisition agreement, Veralox is eligible to receive upfront and milestone payments contingent on the achievement of specified future clinical and regulatory milestones. Additionally, Veralox will be entitled to royalties on global sales of the acquired assets upon future commercialization. The structure and terms of the agreement enable Cadrenal to allocate capital to advancing the clinical development of VLX-1005.

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

Safe Harbor

Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding advancing VLX-1005 for the treatment of HIT; continuing to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the emerging data from VLX-1005 suggesting meaningful potential to improve patient outcomes while maintaining a favorable safety profile; VLX-1005 being a compelling strategic addition to Cadrenal’s pipeline; the payment to Veralox of milestone payments contingent upon the achievement of certain future clinical and regulatory milestones as well as royalties on global sales of the acquired assets upon future commercialization; the structure and terms of the agreement enabling Cadrenal to allocate capital to advancing the clinical development of VLX-1005; and developing transformative therapeutics to overcome the limitations of current anticoagulation therapy. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

For more information, please contact:

Cadrenal Therapeutics:
Matthew Szot, CFO
press@cadrenal.com

Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
CVKD@lythampartners.com

60 Degrees Pharmaceuticals Announces Expansion of ARAKODA® Sales and Marketing in 2026




60 Degrees Pharmaceuticals Announces Expansion of ARAKODA® Sales and Marketing in 2026

• 6-month commercial pilot demonstrated increasing demand among prescribers
• Expansion plan includes doubling the number of sales reps, a new GoodRx partnership, and enhanced digital marketing campaign
• Additional clinical sites in ongoing babesiosis treatment trials will be initiated in light of FDA feedback regarding Company’s breakthrough therapy designation request

WASHINGTON, Dec. 11, 2025 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease, announced today the planned expansion of the Company’s sales and marketing initiatives after encouraging results from a 6-month commercial pilot that showed an overall increase in product sales. The positive outcome points to increasing market demand for ARAKODA^® among prescribers.

In response to the encouraging results, the Company will implement several strategic initiatives designed to expand market reach and accelerate ARAKODA sales in 2026:

• Inside Sales Team Expansion:
  The number of inside sales representatives will increase to deepen outreach across prescribers, strengthen provider relationships, and enhance product education and support.
• GoodRx Partnership for Broader Offer Visibility:
  The Company will engage with GoodRx to provide wider coverage of its point-of-sale (POS) ARAKODA offer, enabling patients and prescribers to access savings information more efficiently.
• Enhanced Digital “Surround Sound” Campaign:

Building on initial successes, the ARAKODA Marketing team will continue to optimize its integrated digital marketing campaign, ensuring high-frequency awareness, relevant targeting, and sustained engagement across prescriber audiences.

“Results of our commercial pilot intended to measure market demand among prescribers demonstrated increasing demand trends,” said Chief Executive Officer, Geoff Dow, PhD. “The investments we plan for 2026 reflect our commitment to expand reach, improve access, and support healthcare providers and patients with what we consider to be best-in-class malaria prevention.”

In addition, the Company will add at least two babesiosis clinical sites for its randomized placebo-controlled study in hospitalized babesiosis patients (NCT06207370) and its expanded access study in high risk patients with treatment refractory relapsing disease (NCT06478641), in response to U.S. Food and Drug Administration (FDA) feedback in a recent communication regarding the Company’s request for Breakthrough Therapy Designation. In declining that request, FDA acknowledged that babesiosis meets the criteria for being classified as a serious or life-threatening disease or condition, one of the requirements for being considered for a Breakthrough Therapy Designation, and suggested that the Company resubmit its request with data from ongoing controlled clinical trials for babesiosis treatment.

The new clinical sites may increase the likelihood of enrolling such patients on a more condensed timeline.

Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for duration of up to six months. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication.

About ARAKODA^® (tafenoquine)

Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA^®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months.

Tafenoquine was discovered by Walter Reed Army Institute of Research, and the current study was funded by the United States Army Medical & Materiel Development Activity. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA^® and in Australia as KODATEF^®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug.

According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less-frequent dosing for prophylaxis for malaria. ARAKODA^® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA^® 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.

ARAKODA^® (tafenoquine) Important Safety Information

ARAKODA^® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older.

Contraindications

ARAKODA^® should not be administered to:

• Glucose-6-phosphate dehydrogenase (“G6PD”) deficiency or unknown G6PD status;
• Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if
• G6PD status is unknown;
• Patients with a history of psychotic disorders or current psychotic symptoms; or
• Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA®.

Warnings and Precautions

Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA^® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.

G6PD Deficiency in Pregnancy or Lactation: ARAKODA^® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA^® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA^® through breast milk. Check infant’s G6PD status before breastfeeding begins.

Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.

Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA^® therapy and evaluation by a mental health professional as soon as possible.

Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA^®. If hypersensitivity reactions occur, institute appropriate therapy.

Delayed Adverse Reactions: Due to the long half-life of ARAKODA^® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.

Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, motion sickness, insomnia, depression, abnormal dreams, and anxiety.

Drug Interactions

Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.

Use in Specific Populations

Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA^®. To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full prescribing information of ARAKODA^® is located here.

About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne disease. The Company achieved U.S. Food and Drug Administration approval of Its lead product, ARAKODA^® (tafenoquine), for malaria prevention, in 2018. ARAKODA is commercially available in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research and academic organizations in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington, D.C., with a subsidiary in Australia. Learn more at www.60degreespharma.com.

The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.

Cautionary Note Regarding Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA^® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward- looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Media Contact:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330

Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma.com

60 Degrees Pharmaceuticals Announces Expansion of ARAKODA® Sales and Marketing in 2026




60 Degrees Pharmaceuticals Announces Expansion of ARAKODA® Sales and Marketing in 2026

• 6-month commercial pilot demonstrated increasing demand among prescribers
• Expansion plan includes doubling the number of sales reps, a new GoodRx partnership, and enhanced digital marketing campaign
• Additional clinical sites in ongoing babesiosis treatment trials will be initiated in light of FDA feedback regarding Company’s breakthrough therapy designation request

WASHINGTON, Dec. 11, 2025 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease, announced today the planned expansion of the Company’s sales and marketing initiatives after encouraging results from a 6-month commercial pilot that showed an overall increase in product sales. The positive outcome points to increasing market demand for ARAKODA^® among prescribers.

In response to the encouraging results, the Company will implement several strategic initiatives designed to expand market reach and accelerate ARAKODA sales in 2026:

• Inside Sales Team Expansion:
  The number of inside sales representatives will increase to deepen outreach across prescribers, strengthen provider relationships, and enhance product education and support.
• GoodRx Partnership for Broader Offer Visibility:
  The Company will engage with GoodRx to provide wider coverage of its point-of-sale (POS) ARAKODA offer, enabling patients and prescribers to access savings information more efficiently.
• Enhanced Digital “Surround Sound” Campaign:

Building on initial successes, the ARAKODA Marketing team will continue to optimize its integrated digital marketing campaign, ensuring high-frequency awareness, relevant targeting, and sustained engagement across prescriber audiences.

“Results of our commercial pilot intended to measure market demand among prescribers demonstrated increasing demand trends,” said Chief Executive Officer, Geoff Dow, PhD. “The investments we plan for 2026 reflect our commitment to expand reach, improve access, and support healthcare providers and patients with what we consider to be best-in-class malaria prevention.”

In addition, the Company will add at least two babesiosis clinical sites for its randomized placebo-controlled study in hospitalized babesiosis patients (NCT06207370) and its expanded access study in high risk patients with treatment refractory relapsing disease (NCT06478641), in response to U.S. Food and Drug Administration (FDA) feedback in a recent communication regarding the Company’s request for Breakthrough Therapy Designation. In declining that request, FDA acknowledged that babesiosis meets the criteria for being classified as a serious or life-threatening disease or condition, one of the requirements for being considered for a Breakthrough Therapy Designation, and suggested that the Company resubmit its request with data from ongoing controlled clinical trials for babesiosis treatment.

The new clinical sites may increase the likelihood of enrolling such patients on a more condensed timeline.

Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for duration of up to six months. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication.

About ARAKODA^® (tafenoquine)

Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA^®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months.

Tafenoquine was discovered by Walter Reed Army Institute of Research, and the current study was funded by the United States Army Medical & Materiel Development Activity. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA^® and in Australia as KODATEF^®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug.

According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less-frequent dosing for prophylaxis for malaria. ARAKODA^® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA^® 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.

ARAKODA^® (tafenoquine) Important Safety Information

ARAKODA^® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older.

Contraindications

ARAKODA^® should not be administered to:

• Glucose-6-phosphate dehydrogenase (“G6PD”) deficiency or unknown G6PD status;
• Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if
• G6PD status is unknown;
• Patients with a history of psychotic disorders or current psychotic symptoms; or
• Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA®.

Warnings and Precautions

Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA^® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.

G6PD Deficiency in Pregnancy or Lactation: ARAKODA^® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA^® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA^® through breast milk. Check infant’s G6PD status before breastfeeding begins.

Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.

Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA^® therapy and evaluation by a mental health professional as soon as possible.

Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA^®. If hypersensitivity reactions occur, institute appropriate therapy.

Delayed Adverse Reactions: Due to the long half-life of ARAKODA^® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.

Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, motion sickness, insomnia, depression, abnormal dreams, and anxiety.

Drug Interactions

Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.

Use in Specific Populations

Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA^®. To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full prescribing information of ARAKODA^® is located here.

About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne disease. The Company achieved U.S. Food and Drug Administration approval of Its lead product, ARAKODA^® (tafenoquine), for malaria prevention, in 2018. ARAKODA is commercially available in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research and academic organizations in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington, D.C., with a subsidiary in Australia. Learn more at www.60degreespharma.com.

The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.

Cautionary Note Regarding Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA^® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward- looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Media Contact:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330

Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma.com

Matisse Pharmaceuticals receives INN isupartob sodium recognizing first-in-class drug status for M6229




Matisse Pharmaceuticals receives INN isupartob sodium recognizing first-in-class drug status for M6229

Geleen, December 11, 2025

Matisse Pharmaceuticals B.V., a clinical stage company developing a medicinal product for the treatment of sepsis, today announced that Matisse’s lead compound M6229, has received the International Non-proprietary Name (INN) isupartob sodium from the World Health Organization. The new class of products ending on the extension –partob, was established by the WHO to define a class of heparin derivatives for histone binders, giving isupartob sodium the recognition as first-in-class product. The INN is a globally recognized, public-domain name that is distinct from a drug’s brand name (trademark) and is crucial for clear and safe communication in medicine and pharmacy.

“We are delighted that isupartob sodium has been recognized as a first-in-class therapy through the award of its International Nonproprietary Name (INN), which includes a new and distinctive suffix. This designation reflects Matisse’s leadership in advancing extracellular histone neutralization as a novel therapeutic approach designed to treat sepsis and other histone induced inflammatory indications”, says Marcel Jacobs, CEO of Matisse Pharmaceuticals.

Matisse will adapt this new name in future communication about the lead compound of Matisse.

About Matisse Pharmaceuticals
Matisse Pharmaceuticals B.V. was founded in 2014 in Geleen, the Netherlands. Matisse is dedicated to develop a product portfolio of safe and innovative therapies for disease indications characterized by elevated levels of circulating cytotoxic histones, such as in sepsis.

Matisse’s lead compound isupartob sodium is based on the discovery that in patients suffering from sepsis, proteins called histones are released into the blood stream by the innate immune system which are toxic to cell membranes leading to cell death and release of additional histones. Due to this self-enforcing cascade, sepsis patients are at risk of death from organ failure. The highly negatively charged isupartob sodium binds to the positively charged extracellular histones and inhibits the self-enforcing cascade of increasing histone levels, thereby preventing further organ damage and death.

After two successful clinical trials in healthy volunteers and sepsis patients, isupartob sodium is now entering clinical phase 2 development.  

About sepsis

According to the WHO, sepsis is one of the leading causes of death worldwide. Currently, there is no effective treatment against sepsis approved by regulatory authorities. From the 49 million patients globally suffering from sepsis every year, more than 20% die. Approximately 40% of the sepsis cases are children under the age of 5, with close to 3 million children not surviving sepsis. According to a study by Buchman et al. (2020), published in Critical Care Medicine, sepsis is the most common cause of in-hospital deaths, costing over $62 billion annually in the USA alone.

For more information, please contact:

Marcel Jacobs, CEO
(T) +31 6 575 27 541
(E) info@matissepharmaceuticals.com
(W) www.matissepharmaceuticals.com

Attachments

• 20251211 (NL) Matisse ontvang INN isupartob sodium (final)
• isupartob sodium product picture

60 Degrees Pharmaceuticals Announces Expansion of ARAKODA® Sales and Marketing in 2026




60 Degrees Pharmaceuticals Announces Expansion of ARAKODA® Sales and Marketing in 2026

• 6-month commercial pilot demonstrated increasing demand among prescribers
• Expansion plan includes doubling the number of sales reps, a new GoodRx partnership, and enhanced digital marketing campaign
• Additional clinical sites in ongoing babesiosis treatment trials will be initiated in light of FDA feedback regarding Company’s breakthrough therapy designation request

WASHINGTON, Dec. 11, 2025 (GLOBE NEWSWIRE) — 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (“60 Degrees Pharma” or the “Company”), a pharmaceutical company focused on developing new medicines for vector-borne disease, announced today the planned expansion of the Company’s sales and marketing initiatives after encouraging results from a 6-month commercial pilot that showed an overall increase in product sales. The positive outcome points to increasing market demand for ARAKODA^® among prescribers.

In response to the encouraging results, the Company will implement several strategic initiatives designed to expand market reach and accelerate ARAKODA sales in 2026:

• Inside Sales Team Expansion:
  The number of inside sales representatives will increase to deepen outreach across prescribers, strengthen provider relationships, and enhance product education and support.
• GoodRx Partnership for Broader Offer Visibility:
  The Company will engage with GoodRx to provide wider coverage of its point-of-sale (POS) ARAKODA offer, enabling patients and prescribers to access savings information more efficiently.
• Enhanced Digital “Surround Sound” Campaign:

Building on initial successes, the ARAKODA Marketing team will continue to optimize its integrated digital marketing campaign, ensuring high-frequency awareness, relevant targeting, and sustained engagement across prescriber audiences.

“Results of our commercial pilot intended to measure market demand among prescribers demonstrated increasing demand trends,” said Chief Executive Officer, Geoff Dow, PhD. “The investments we plan for 2026 reflect our commitment to expand reach, improve access, and support healthcare providers and patients with what we consider to be best-in-class malaria prevention.”

In addition, the Company will add at least two babesiosis clinical sites for its randomized placebo-controlled study in hospitalized babesiosis patients (NCT06207370) and its expanded access study in high risk patients with treatment refractory relapsing disease (NCT06478641), in response to U.S. Food and Drug Administration (FDA) feedback in a recent communication regarding the Company’s request for Breakthrough Therapy Designation. In declining that request, FDA acknowledged that babesiosis meets the criteria for being classified as a serious or life-threatening disease or condition, one of the requirements for being considered for a Breakthrough Therapy Designation, and suggested that the Company resubmit its request with data from ongoing controlled clinical trials for babesiosis treatment.

The new clinical sites may increase the likelihood of enrolling such patients on a more condensed timeline.

Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for duration of up to six months. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication.

About ARAKODA^® (tafenoquine)

Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA^®. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator or placebo-controlled trials for durations of up to six months.

Tafenoquine was discovered by Walter Reed Army Institute of Research, and the current study was funded by the United States Army Medical & Materiel Development Activity. Tafenoquine was approved for malaria prophylaxis in 2018 in the United States as ARAKODA^® and in Australia as KODATEF^®. Both were commercially launched in 2019 and are currently distributed through pharmaceutical wholesaler networks in each respective country. They are available at retail pharmacies as a prescription-only malaria prevention drug.

According to the Centers for Disease Control and Prevention, the long terminal half-life of tafenoquine, which is approximately 16 days, may offer potential advantages in less-frequent dosing for prophylaxis for malaria. ARAKODA^® is not suitable for everyone, and patients and prescribers should review the Important Safety Information below. Individuals at risk of contracting malaria are prescribed ARAKODA^® 2 x 100 mg tablets once per day for three days (the loading phase) prior to travel to an area of the world where malaria is endemic, 2 x 100 mg tablets weekly for up to six months during travel, then 2 x 100 mg in the week following travel.

ARAKODA^® (tafenoquine) Important Safety Information

ARAKODA^® is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years of age and older.

Contraindications

ARAKODA^® should not be administered to:

• Glucose-6-phosphate dehydrogenase (“G6PD”) deficiency or unknown G6PD status;
• Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if
• G6PD status is unknown;
• Patients with a history of psychotic disorders or current psychotic symptoms; or
• Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA®.

Warnings and Precautions

Hemolytic Anemia: G6PD testing must be performed before prescribing ARAKODA^® due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis.

G6PD Deficiency in Pregnancy or Lactation: ARAKODA^® may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus. ARAKODA^® is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA^® through breast milk. Check infant’s G6PD status before breastfeeding begins.

Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur.

Psychiatric Effects: Serious psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose. If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA^® therapy and evaluation by a mental health professional as soon as possible.

Hypersensitivity Reactions: Serious hypersensitivity reactions have been observed with administration of ARAKODA^®. If hypersensitivity reactions occur, institute appropriate therapy.

Delayed Adverse Reactions: Due to the long half-life of ARAKODA^® (approximately 16 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration.

Adverse Reactions: The most common adverse reactions (incidence greater than or equal to 1 percent) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase, motion sickness, insomnia, depression, abnormal dreams, and anxiety.

Drug Interactions

Avoid co-administration with drugs that are substrates of organic cation transporter-2 or multidrug and toxin extrusion transporters.

Use in Specific Populations

Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA^®. To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals, Inc. at 1- 888-834-0225 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The full prescribing information of ARAKODA^® is located here.

About 60 Degrees Pharmaceuticals, Inc.
60 Degrees Pharmaceuticals, Inc., founded in 2010, specializes in developing and commercializing new medicines for the treatment and prevention of vector-borne disease. The Company achieved U.S. Food and Drug Administration approval of Its lead product, ARAKODA^® (tafenoquine), for malaria prevention, in 2018. ARAKODA is commercially available in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. also collaborates with prominent research and academic organizations in the U.S. and Australia. 60 Degrees Pharmaceuticals, Inc. is headquartered in Washington, D.C., with a subsidiary in Australia. Learn more at www.60degreespharma.com.

The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management’s current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.

Cautionary Note Regarding Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward‐looking statements reflect the current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward‐looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, activities of regulators and future regulations and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: there is substantial doubt as to our ability to continue on a going-concern basis; we might not be eligible for Australian government research and development tax rebates; if we are not able to successfully develop, obtain FDA approval for, and provide for the commercialization of non-malaria prevention indications for tafenoquine (ARAKODA^® or other regimen) or Celgosivir in a timely manner, we may not be able to expand our business operations; we may not be able to successfully conduct planned clinical trials or patient recruitment in our trials might be slow or negligible; and we have no manufacturing capacity which puts us at risk of lengthy and costly delays of bringing our products to market. More detailed information about the Company and the risk factors that may affect the realization of forward- looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the information contained in our Annual Report on Form 10-K filed with the SEC on April 1, 2024, and our subsequent SEC filings. Investors and security holders are urged to read these documents free of charge on the SEC’s website at www.sec.gov. As a result of these matters, changes in facts, assumptions not being realized or other circumstances, the Company’s actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Media Contact:
Sheila A. Burke
SheilaBurke-consultant@60degreespharma.com
(484) 667-6330

Investor Contact:
Patrick Gaynes
patrickgaynes@60degreespharma.com

Matisse Pharmaceuticals receives INN isupartob sodium recognizing first-in-class drug status for M6229




Matisse Pharmaceuticals receives INN isupartob sodium recognizing first-in-class drug status for M6229

Geleen, December 11, 2025

Matisse Pharmaceuticals B.V., a clinical stage company developing a medicinal product for the treatment of sepsis, today announced that Matisse’s lead compound M6229, has received the International Non-proprietary Name (INN) isupartob sodium from the World Health Organization. The new class of products ending on the extension –partob, was established by the WHO to define a class of heparin derivatives for histone binders, giving isupartob sodium the recognition as first-in-class product. The INN is a globally recognized, public-domain name that is distinct from a drug’s brand name (trademark) and is crucial for clear and safe communication in medicine and pharmacy.

“We are delighted that isupartob sodium has been recognized as a first-in-class therapy through the award of its International Nonproprietary Name (INN), which includes a new and distinctive suffix. This designation reflects Matisse’s leadership in advancing extracellular histone neutralization as a novel therapeutic approach designed to treat sepsis and other histone induced inflammatory indications”, says Marcel Jacobs, CEO of Matisse Pharmaceuticals.

Matisse will adapt this new name in future communication about the lead compound of Matisse.

About Matisse Pharmaceuticals
Matisse Pharmaceuticals B.V. was founded in 2014 in Geleen, the Netherlands. Matisse is dedicated to develop a product portfolio of safe and innovative therapies for disease indications characterized by elevated levels of circulating cytotoxic histones, such as in sepsis.

Matisse’s lead compound isupartob sodium is based on the discovery that in patients suffering from sepsis, proteins called histones are released into the blood stream by the innate immune system which are toxic to cell membranes leading to cell death and release of additional histones. Due to this self-enforcing cascade, sepsis patients are at risk of death from organ failure. The highly negatively charged isupartob sodium binds to the positively charged extracellular histones and inhibits the self-enforcing cascade of increasing histone levels, thereby preventing further organ damage and death.

After two successful clinical trials in healthy volunteers and sepsis patients, isupartob sodium is now entering clinical phase 2 development.  

About sepsis

According to the WHO, sepsis is one of the leading causes of death worldwide. Currently, there is no effective treatment against sepsis approved by regulatory authorities. From the 49 million patients globally suffering from sepsis every year, more than 20% die. Approximately 40% of the sepsis cases are children under the age of 5, with close to 3 million children not surviving sepsis. According to a study by Buchman et al. (2020), published in Critical Care Medicine, sepsis is the most common cause of in-hospital deaths, costing over $62 billion annually in the USA alone.

For more information, please contact:

Marcel Jacobs, CEO
(T) +31 6 575 27 541
(E) info@matissepharmaceuticals.com
(W) www.matissepharmaceuticals.com

Attachments

• 20251211 (NL) Matisse ontvang INN isupartob sodium (final)
• isupartob sodium product picture

Geron Corporation Announces Strategic Restructuring Plan to Position the Company for Long-Term Value Creation




Geron Corporation Announces Strategic Restructuring Plan to Position the Company for Long-Term Value Creation

Restructuring Supports RYTELO^® U.S. Commercial Strategy and Investment in Clinical Development

Expected to Reduce 2026 Projected Operating Expenses

FOSTER CITY, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) — Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced a strategic restructuring plan intended to position the Company for long-term value creation for patients and shareholders and improve its financial discipline.

“After my first four months at Geron, the leadership team and I have assessed the business with the goal of streamlining our organizational structure to advance our strategy and create long-term value. We are implementing these changes from a position of strength and in the spirit of prudent fiscal management,” said Harout Semerjian, President and Chief Executive Officer of Geron. “Our key objectives remain unchanged. We are focused on driving RYTELO commercial growth in the U.S., exploring opportunities for making RYTELO available outside the U.S., and continuing to advance our Phase 3 IMpactMF trial. We expect this restructuring will have a meaningful impact on our 2026 operating expenses and position Geron to meet the needs of patients. I want to express my gratitude to the employees that will be impacted in this restructuring. Your contributions over the years have made a positive difference in the lives of the people we endeavor each day to assist.”

The Company’s strategic restructuring plan is expected to result in an approximately one-third reduction in Geron’s current workforce of approximately 260 employees. As a result of the restructuring plan, which is expected to be substantially complete in the first quarter of 2026, initial projected full year 2026 operating expenses are expected to be less than the Company’s projected full year 2025 operating expenses, with savings expected to be realized beginning in the first quarter of 2026. Geron will incur restructuring charges consisting primarily of cash-based expenses in connection with the restructuring plan, with additional information to be provided in a Current Report on Form 8-K to be filed with the Securities and Exchange Commission. Geron thanks all employees who will be impacted by today’s announcement for their contributions to the Company.

About Geron
Geron is a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer. Our first-in-class telomerase inhibitor RYTELO (imetelstat) is approved in the United States and the European Union for the treatment of certain adult patients with LR-MDS with transfusion-dependent anemia. We are also conducting a pivotal Phase 3 clinical trial of imetelstat in JAK-inhibitor R/R MF, as well as studies in other hematologic malignancies. Inhibiting telomerase activity, which is increased in malignant stem and progenitor cells in the bone marrow, aims to potentially reduce proliferation and induce death of malignant cells. To learn more, visit www.geron.com or LinkedIn.

Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) the Company’s belief that the restructuring plan will streamline the Company’s organizational structure, advance its strategy, position the Company for long-term value creation for patients and shareholders, support RYTELO commercial strategy and investment in clinical development, and improve financial discipline; (ii) the Company’s focus on driving RYTELO commercial growth in the U.S., exploring opportunities for making RYTELO available outside the U.S., and continuing to advance its Phase 3 IMpactMF trial; (iii) the Company’s expectation that the restructuring will have a meaningful impact on its 2026 operating expenses and position the Company to meet the needs of patients; (iv) the expected size of the reduction in workforce and the Company’s expectations that initial projected full year 2026 operating expenses will be lower than projected full year 2025 operating expenses, with savings expected to be realized beginning in the first quarter of 2026; (v) the expected costs and timing for completion of the restructuring; and (vi) other statements that are not historical facts, constitute forward-looking statements. These forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (a) whether Geron is successful in commercializing RYTELO (imetelstat) for the treatment of certain patients with lower-risk MDS with transfusion dependent anemia and achieves market acceptance across the breadth of the eligible patient segments in RYTELO’s approved indication; (b) whether the FDA and European Commission will approve imetelstat for other indications on the timelines expected, or at all; (c) Geron’s plans to commercialize RYTELO in the European Union, or EU, and risks related to operating outside of the U.S.; (d) whether Geron overcomes potential delays and other adverse impacts that may be caused by enrollment, clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to have the financial resources for and meet expected timelines and planned milestones; (e) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (f) whether any future safety or efficacy results of RYTELO treatment cause its benefit-risk profile to become unacceptable; (g) whether imetelstat actually demonstrates disease-modifying activity in patients and the ability to target the malignant stem and progenitor cells of the underlying disease; (h) whether Geron meets its post-marketing requirements and commitments for RYTELO; (i) whether there are failures or delays in manufacturing or supplying sufficient quantities of RYTELO (imetelstat) or other clinical trial materials that impact commercialization of RYTELO or the continuation of clinical trials; (j) that the projected timing for the interim and final analyses of the Phase 3 IMpactMF trial in R/R MF may vary depending on actual death rates in the trial; (k) whether Geron stays in compliance with and satisfies its obligations under its debt and synthetic royalty financing agreements; and (l) whether Geron successfully completes its restructuring plan, manages the changes in its workforce, and realizes expected operating expense savings. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s filings and periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors” and elsewhere in such filings and reports, including Geron’s quarterly report on Form 10-Q for the quarter ended September 30, 2025, and subsequent filings and reports by Geron. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events, or circumstances.

Investors and Media
Dawn Schottlandt
Senior Vice President, Investor Relations and Corporate Affairs
dschottlandt@geron.com